Daiichi Sankyo and Lilly Respond to Speculation on Status of Prasugrel New Drug Application

... TOKYO and INDIANAPOLIS Oct. 16 /- In respo... Daiichi Sankyo and Lilly are engaged in an ongoing dialogue with the... The FDA can schedule an Advisory Committee at any time during therev...Lilly on behalf of its alliance partner Daiichi Sankyo submitted a...

TOKYO and INDIANAPOLIS, Oct. 16 /PRNewswire-FirstCall/ -- In response
to recent media speculation regarding the status of the prasugrel new drug
application (NDA), Daiichi Sankyo Company, Limited (TSE: 4568) and Eli
Lilly and Company (NYSE: LLY) reiterated today that they continue to have
discussions with the FDA regarding the review of this application. The
companies have not been notified of any regulatory action for the new drug
application (NDA) or of any decision to have an advisory committee to
review prasugrel. Prasugrel is an investigational antiplatelet agent for
the treatment of patients with acute coronary syndromes (ACS) who are being
managed with an artery-opening procedure known as percutaneous coronary
intervention (PCI), which is usually followed by the placement of a stent
to help keep the artery open.

"Daiichi Sankyo and Lilly are engaged in an ongoing dialogue with the
FDA," said Jennifer Stotka, M.D., Lilly vice president of Global Regulatory
Affairs. "We remain confident in the overall benefit-risk profile of
prasugrel, and we believe this drug should be approved so that we can bring
this valuable treatment option to ACS patients, a population at risk for
further cardiovascular events."

"The FDA can schedule an Advisory Committee at any time during the
review of an application. If one is called, then we will be prepared to
participate," said John Alexander, M.D., M.P.H., global head of research
and development, Daiichi Sankyo Company, Limited.

Lilly, on behalf of its alliance partner, Daiichi Sankyo, submitted a
new drug application to the FDA for prasugrel in December 2007. Lilly, on
behalf of the alliance, also submitted a Marketing Authorization
Application for prasugrel to the European Medicines Agency in February
2008.

In the TRITON-TIMI 38 clinical trial of more than 13,000 patients, the
primary measure showed that prasugrel taken with aspirin reduced the
relative risk of the combined endpoint of cardiovascular death, non-fatal
heart attacks or non-fatal stroke by 19 percent more than clopidogrel
(Plavix(R)/Iscover(R)) taken with aspirin. These benefits were accompanied
by an increased risk of serious bleeding with prasugrel overall, some of
which may be life threatening. Overall, for every 1,000 people treated,
there were six more TIMI major bleeding events, but 23 fewer heart attacks
in patients taking prasugrel compared with patients taking clopidogrel(i).
The risk of cardiovascular death overall in the study was not statistically
different between treatment groups [prasugrel (2.0%) compared with
clopidogrel (2.2%)].

About Daiichi Sankyo Company, Limited

A global pharma innovator, Daiichi Sankyo Co., Ltd., was established in
2005 through the merger of two leading Japanese pharmaceutical companies.
This integration created a more robust organization that allows for
continuous development of novel drugs that enrich the quality of life for
patients around the world. A central focus of Daiichi Sankyo's research and
development is cardiovascular disease, including therapies for
dyslipidemia, hypertension, diabetes, and acute coronary syndrome. Equally
important to the company is the discovery of new medicines in the areas of
infectious diseases, cancer, bone and joint diseases, and immune disorders.
For more information, visit http://www.daiichisankyo.com.

Daiichi Sankyo, Inc. (http://www.dsus.com) headquartered in Parsippany, New
Jersey, is the U.S. subsidiary of Daiichi Sankyo Co., Ltd.

About Eli Lilly and Company

Lilly, a leading innovation-driven corporation, is developing a growing
portfolio of first-in-class and best-in-class pharmaceutical products by
applying the latest research from its own worldwide laboratories and from
collaborations with eminent scientific organizations. Headquartered in
Indianapolis, Ind., Lilly provides answers - through medicines and
information - for some of the world's most urgent medical needs.

P-LLY

Plavix is a registered trademark of Sanofi Aventis Corp.

This press release contains certain forward-looking statements about
the potential of the investigational compound prasugrel (CS-747, LY640315)
and reflects Daiichi Sankyo's and Lilly's current beliefs. However, as with
any pharmaceutical compound under development, there are substantial risks
and uncertainties in the process of development and regulatory review.
There is no guarantee that the compound will receive regulatory approval,
that the regulatory approval will be for the indication(s) anticipated by
the companies, or that later studies and patient experience will be
consistent with study findings to date. There is also no guarantee that the
compound will prove to be commercially successful. For further discussion
of these and other risks and uncertainties, see Lilly's filing with the
United States Securities and Exchange Commission and Daiichi Sankyo's
filings with the Tokyo Stock Exchange. Daiichi Sankyo and Lilly undertake
no duty to update forward-looking statements.

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